Letters for Issue on 11.11.2014

LETTERS FOR ISSUE ON 11.11.2014 COSMETICS DIVISION

S.NO COMPANY NAME DIARY NO STATUS .

1. M/s. Universal Distributors Pvt. Ltd, Mumbai 36098 Approval letter

2. M/s. Madaus Pharmaceuticals Pvt. Ltd, Goa 33365, Approval 33366, Letter 33367 3. M/s. Siberian Health International Private Limited, 34321 Approval New Delhi Letter

4. M/s. Sislong Traders Pvt. Ltd, Bangalore 36669 Approval Letter

5. M/s. G.S. Pharmabutor Pvt. Ltd, Uttarakhand 33929 Approval Letter

6. M/s. Indreus Living Pvt. Ltd, Mumbai 34827 Approval Letter

7. M/s. Jafra Ruchi Cosmetics India Pvt. Ltd, New 34803 Approval Delhi Letter

8. M/s. KNS Trading Private Limited, New Delhi 33825 Approval Letter

9. M/s. Sephora Cosmetics Private Limited, New 34826 Approval Delhi Letter

10. M/s. Akumentis Healthcare Limited, Thane(W), 35809, Deficiency Mumbai 35811 Letter

11. M/s. Johnson & Johnson Ltd, Mumbai 36659 Deficiency Letter

GLOBAL CLINICAL TRIAL Sr. No. Name of Firm Reference No. Type of Letter

1. M/s. MSD 45197 CT NOC Approval

2. M/s. Manipal Acunova 8641 CT NOC Approval

3. M/s. PPD 35619/6898 CT NOC Approval letters

4. M/s. Novo Nordisk 41242 Change in PI Approval

5. M/s. APL Research 28635/39853 Amendment in TL &Clarification Letter

6. M/s. Pfizer 12783 PA Approval Letter

7. M/s. Maya Clinicals 40627 Change In Pi Approval

8. M/s. Novartis 37860 CT NOC Approval

9. M/s. Boehringer 10461 PA Approval

BE NOC FOR EXPORT

S. NO. NAME OF THE COMPANY REF. NO. Type of letter

1. M/s. Alembic Pharmaceuticals Ltd., 43228 Approval Letter Vadodara-390 003

2. M/s. Axis Clinical Ltd., Hyderabad-500 43231 Approval Letter 049

3. M/s. Axis Clinical Ltd., Hyderabad-500 35180 Approval Letter 049

4. M/s. Azidus Laboratories Ltd., Chennai- 42532 Clarification 600 048 Letter

5. M/s. Azidus Laboratories Ltd., Chennai- 43115 Approval Letter 600 048

6. M/s. Azidus Laboratories Ltd., Chennai- 43113 Approval Letter 600 048

7. M/s. Cipla Limited, Mumbai-400 008 43216 Approval Letter 8. M/s. Cliantha Research Limited, 43473 Approval Letter Ahmedabad-380 054

9. M/s. Cliantha Research Limited, 43552 Approval Letter Ahmedabad-380 054

12. M/s. Clinsync Clinical Research Pvt. Ltd., 42347 Amendment Hyderabad-501 505 Letter

13. M/s. Glenmark Generics Ltd., Navi 19532 Approval Letter Mumbai-400 705

14. M/s. Kusum Healthcare Pvt. Ltd., New 43108 Approval Letter Delhi-110 020

15. M/s. Lambda Therapeutic Research Ltd., 43058 Approval Letter Ahmedabad-380 061

16. M/s. Manipal Acunova Limited, Manipal 43054 Approval Letter -576104

17. M/s. Micro Therapeutic Research Labs 31202 Amendment Pvt. Ltd., Chennai-600 059 Letter

18. M/s. Piramal Clinical Research, 43125 Approval Letter Hydearbad-500 013

19. M/s. Ranbaxy Laboratories Ltd., Gurgaon- 43435 Approval Letter 122 015

20. M/s. Sun Pharmaceutical Industries Ltd., 43302 Approval Letter Vadodara-390 020

21. M/s. Veeda Clinical Research Pvt. Ltd., 41358 Approval Letter Ahmedabad-380 015 LETTER PERTAINING TO REGISRATION

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. DIVINNE SBR INTERNATIONAL 34737 2 CLARIFICATION PVT. LTD. LETTER

MEDICAL DEVICE S.NO. COMPANY NAME DIARY NO STATUS

1. M/s.Accredited Consultants Pvt. Ltd. 35217 Approval (F-RC)

2. M/s. Accredited Consultants Pvt. Ltd. 35217 Approval (F-IL)

3. M/s. Johnson & Johnson Ltd. 42548 Approval (F-RC)

4. M/s. Johnson & Johnson Ltd. 42548 Approval (F-IL)

5. M/s. Medionics India Pvt. Ltd. 39688 Approval (R-RC)

6. M/s. Medionics India Pvt. Ltd. 39688 Approval (R-IL)

7. M/s. 3M India Limited. 36435 Approval (E-RC)

8. M/s. B L Lifesciences Pvt. Ltd. 42352 Approval (F-IL)

9. M/s. Medi Focus India (D) Ltd. 39703 Approval (F-IL)

10. M/s. Medishare Inc. 38552 Approval (F-IL)

11. M/s. Covidien Healthcare India Pvt. Ltd. 333276 Approval Letter

12. M/s. Johnson & Johnson Ltd. 34734 Letter

13. M/s. Abbott Healthcare Pvt. Ltd. 35981 Letter

14. M/s. Johnson & Johnson Ltd. 30041 Letter

15. M/s. India Medtroninc Pvt. Ltd. 34194 Query Letter

16. M/s. Phoenix Cardio Care India Pvt. Ltd. 36866 Query Letter

17. M/s. Stryker India Pvt. Ltd. 34744 Query Letter

18. M/s. Stryker India Pvt. Ltd. 32944 Query Letter

19. M/s. Meril Life Sciences India Pvt. Ltd. 34194 Letter 20. M/s. Phoenix Cardio Care India Pvt. Ltd. 36846 Letter

All port offices of CDSCO

21. M/s. Johnson & Johnson Ltd. 22343 Query Letter

22. M/s. Biomet Orthopaedic India Pvt. Ltd. 23304 Query Letter

23. M/s. Osstem Implant India Pvt. Ltd. 22380 Query Letter

24. M/s. Abbott Healthcare Pvt. Ltd. 32537 Query Letter

25. The Drugs Licensing Authority, Daman Nil Letter

26. M/s. Kanji Shavji Parekh (Calcutta) Pvt. Ltd. 59334 Query Letter

27. M/s. Smith & Nephew Healthcare Pvt. Ltd. 32818 Letter

28. M/s. Lifecare Devices Pvt. Ltd. 41994 Letter

DIAGNOSTIC DIVISION

S.NO. COMPANY NAME DIARY NO STATUS

1. M/s.Roche Diagnostics India Pvt. Ltd. 22695 Approval (E-RC)

2. M/s. Roche Diagnostics India Pvt. Ltd. 22695 Approval (E-IL)

3. M/s. Alere Medical Pvt. Ltd. 33808 Approval (IL)

4. M/s. Biosystems Diagnostics Pvt. Ltd. 35739 Approval (IL)

5. M/s. Sandor Medicaids Pvt. Ltd. 35331 Approval (IL)

6. M/s. Vishat Diagnostics Pvt. Ltd. 38502 Approval (TL)

All port offices of CDSCO 7. M/s. Alere Medical Pvt. Ltd. 33808 Query Letter

8. M/s. Vishat Diagnostics Pvt. Ltd. 38502 Query Letter

9. M/s. Beckamn Coulter India Pvt. Ltd. 38411 Query Letter

10. M/s. Doshi Medical Service Pvt. Ltd. 40217 Query Letter

GLOBAL CLINICAL TRIAL

Sr. No. Name of Firm Reference No. Type of Letter

1. M/s. MSD 45197 CT NOC Approval

2. M/s. Manipal Acunova 8641 CT NOC Approval

3. M/s. PPD 35619/6898 CT NOC Approval letters

4. M/s. Novo Nordisk 41242 Change in PI Approval

5. M/s. APL Research 28635/39853 Amendment in TL &Clarification Letter

6. M/s. Pfizer 12783 PA Approval Letter

7. M/s. Maya Clinicals 40627 Change In Pi Approval

8. M/s. Novartis 37860 CT NOC Approval

9. M/s. Boehringer 10461 PA Approval

VACCINE DIVISION

S. No. COMPANY NAME Dy. No. STATUS

1 M/s Institute of Animal 58278 (fts no) Approval Letter Health & Veterinary Biologicals 2 M/s Hester Biosciences 21448, 21455 Approval Letter ltd

3 M/s Regenerative Clarification Letter Medical Services Pvt, ltd 7 M/s Hipra (I) Ltd Clarification Letter

8 M/s Reliance Life 39446 Approval Letter Sciences Pvt, ltd 15 M/s Zoetis India ltd 25361 Approval Letter

16 M/s Virbac Animal 31758 Approval Letter Health India Pvt, ltd

EXPORT OF BIOLOGICAL SAMPLES

S. No. COMPANY NAME Dy. No. STATUS

1 M/s Lambda 42692 Approval letter Therapeutic Research Ltd 2 M/s Veeda Clinical 39933, 43141, Approval letter Research Pvt, ltd 43140, 39932 3 M/s Cliantha Research 40102 Approval letter Ltd 4 M/s Accutest Research 43049, 42074 Approval letter Laboratories Pvt, ltd